RecruitingPhase 1Phase 2NCT07461220

Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy

A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants With Parkinson's Disease and Apathy

Sponsor

Integrative Research Laboratories AB

Enrollment

75 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Safety PARKINSON DISEASE (Disorder)Apathy

Summary

This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation). In addition, the trial is aiming to learn if IRL757 has effects on the symptoms of Parkinson's disease. Researchers will compare the effects of IRL757 to a placebo (a look-alike substance that contains no drug). Participants who fit the study criteria will be treated with the study drug (either the active drug IRL757 or placebo) for 12 weeks and will visit the clinic at 5 defined timepoints for check-ups and tests. A follow-up call after the end of treatment will be done 4 weeks after the last study drug intake.

Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called IRL757 to see if it is safe and well-tolerated in people with Parkinson's disease who also experience apathy — a persistent lack of motivation, interest, or initiative that is separate from depression. **You may be eligible if...** - You are between 50 and 90 years old - You have been diagnosed with Parkinson's disease - You experience noticeable apathy — less initiative, interest, or emotional response — at least 3 days a week for 4 or more weeks - Your Parkinson's disease is not at its most severe stage - Your thinking and memory are reasonably intact (MoCA score of 20 or above) **You may NOT be eligible if...** - Your Parkinson's disease is very advanced (Hoehn and Yahr stage 5) - You have significant memory or thinking problems - You do not meet the specific apathy criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIRL757

IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration.

DRUGPlacebo

The study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally.

Locations(13)

Medical Center "Galileo" OOD

Pleven, Bulgaria

First University Multiprofile Hospital for Active Treatment MHAT - Neurology Clinic

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment "Alexandrovska" EAD, Clinic of Neurological Diseases

Sofia, Bulgaria

Neurologie Berlin

Berlin, Germany

Universitaetsklinikum Carl Gustav Carus

Dresden, Germany

Centrum Medyczne NEUROMED

Bydgoszcz, Poland

Neuro-Care sp. z o.o. sp. Komandytowa

Katowice, Poland

NeuroKlinika Prof. Andrzej Bogucki

Lodz, Poland

EuroMedis Sp. z o.o.

Szczecin, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

Hospital de la Santa Creu i Sant Pau, Unidad de trastornos del movimiento

Barcelona, Spain

Hospital General Universitario de Elche

Elche, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07461220

Related Trials

The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease

NCT073061042 locations

Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease

NCT075577061 location

Short and Long-term Responses of PD Symptoms to Earstim

NCT074007312 locations

Effects of an Independent Walking Program With Walking Poles in People With Parkinson Disease

NCT075516611 location

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

NCT074226756 locations